Fluent Essays

Reflect on the content assigned for Week #3 using the below questions as a guide, at a minimum:How important was establishing drug standards to the evolution of pharmacy as a profession?The USP is celebrating its bicentennial in 2020. How relevant is it today?What made you curious about this weeks content?As the American pharmaceutical industry matured, what has been the primary positive things that have occurred? What have been the most negative things?What impact has the maturation of the pharmaceutical industry had on health care in the United States?Are there parallels between the late 1910s and today (100 + years later)?Please use 12-point, Times New Roman font with 1.5 or 2.0 spacingMinimum 2 pages of reflection At least 3 cited sources Thank you. week_3_reflection_document.pdf mccarthy_8_pharmacoepeia.pdf mccarthy_5_industry.pdf aihp_pharmaceuticalindustry.pptx Unformatted Attachment Preview Week #3 Reflection Pharmacopeia Please read, view, and reflect on the following materials: -Dr. Robert McCarthy PowerPoint (McCarthy-8-Pharmacoepiea attached document) Industry Please read, view, and reflect on the following materials: -Dr. Don Vogt and Dr. Michael Montagne Articles ֎ Process of Pharmaceutical Development: I available at the following URL : https://www.researchgate.net/publication/249017438_The_Process_of_Drug_Development_I_The_His torical_Interplay_of_Political_Economics_Research_and_Regulation ֎ Process of Pharmaceutical Development: II available at the following URL: https://www.researchgate.net/publication/240534302_The_Process_of_Drug_Development_II_The_His torical_Interplay_of_Therapeutics_Clinical_Research_and_Scientific_Education -Dr. Robert McCarthy PowerPoint (McCarthy-5-Industry attached document) -AIHP PowerPoint (AIHP-PhamaceuticalIndustry attached document) Reflection instructions can be found below: Reflect on the content assigned for Week #3 using the below questions as a guide, at a minimum: • • • • • • How important was establishing drug standards to the evolution of pharmacy as a profession? The USP is celebrating its bicentennial in 2020. How relevant is it today? What made you curious about this weeks content? As the American pharmaceutical industry matured, what has been the primary positive things that have occurred? What have been the most negative things? What impact has the maturation of the pharmaceutical industry had on health care in the United States? Are there parallels between the late 1910s and today (100 + years later)? Rennebohm Hall n University of Wisconsin-Madison School of Pharmacy 777 Highland Avenue n Madison, WI 53705-2222 n 608.262.5378 n aihp@aihp.org This slide presentation was compiled and produced by Robert McCarthy, Ph.D., Professor and Dean Emeritus at the University of Connecticut School of Pharmacy for his class “The History of American Pharmacy.” Prof. McCarthy created this version of the slide talk for his class in the Spring of 2016. This slide presentation was downloaded from the Teaching the History of Pharmacy section of the website of the American Institute of the History of Pharmacy (https://aihp.org/historicalresources/teaching-the-history-of-pharmacy/) where a copy of the syllabus (.pdf) for Prof. McCarthy’s class is also available. This .pdf copy of the slide presentation was shared with the permission of Prof. Robert McCarthy for the personal and educational use of interested readers. EVOLUTION OF THE PHARMACOPOEIA PHRX 4001W-002 The History of American Pharmacy Spring 2016 An American Pharmacopeia • 1808: The Massachusetts Pharmacopoeia is published providing a state guide to drug standards. • The Massachusetts Pharmacopoeia was used by apothecaries to properly fill prescriptions from physicians since it defined the identity of drugs and preparations. • 1820: The U.S. Pharmacopeial Convention founded in Washington, DC; although all state medical societies were invited to send delegates, only 11 states attended; only about 200 drugs were included in the first USP since they were the only ones deemed “most fully established and best understood.” United States Pharmacopoeia (USP) • 1830: The first revision of the USP published; revisions continue at an interval of every 10 years. • 1848: Congress passes legislation making the USP an official compendium. • 1888: First National Formulary (NF) published by the American Pharmaceutical (now Pharmacists) Association. • 1900: USP Convention and Board of Trustees created. • 1906: USP and NF standards for strength, quality, and purity recognized as official. United States Pharmacopoeia (USP) • 1938: USP and NF standards for strength, quality, purity, packaging, and labeling recognized as official and enforced by FDA; New Drug concept established; FDA approves drugs for safety before marketing. • 1942: USP revision cycle changed to every 5 years. • 1971: USP moves headquarters to Rockville, MD. • 1975: USP acquires NF from APhA. • 1977: USP and NF scope redefined: USP specifies standards for drug substances and dosage forms; NF specifies standards for excipients. • 1980: USP and NF published under same cover; USP Dispensing Information (USP DI) published. • 1993: Federal Omnibus Budget Reconciliation Acts (OBRA 90 and 93) name USP DI as source of information that state Medicaid agencies can use for drug utilization review, patient counseling, and medically accepted off-label uses of medicines. United States Pharmacopoeia (USP) • 1994: USP signs an agreement with the American Medical Association to combine the information in AMAs Drug Evaluations database with the USP DI database to develop a single product that contains drug and therapeutic information. • 2002: USP-NF published annually. • 2000s: USP develops offices/laboratories around the world and collaborates with the pharmacopoeias of other nations in developing drug standards. Source: USP Web Site National Formulary • 1883: NY Pharmacist Samuel Bendiner and NY hospital pharmacist Charles Rice led an effort to modernize the US Pharmacopoeia; Bendiner inspired the creation of the New York and Brooklyn Formulary (NYBF); Rice negotiated an agreement to share the information in the NYBF to develop a national formulary, which it was hoped would be used by physicians in prescribing rather than recommending the use of proprietary medicines. • 1886: APhA published a preliminary draft of the National Formulary of Unofficinal Preparations, asking for feedback from the pharmacy profession. • 1888: The National Formulary (NF) is published for the first time by APhA. • 1906: The second revision of the NF coincides with the passage of the Food & Drug Act, which named the NF as one of the official standards for pharmaceuticals, much to the surprise of APhA. National Formulary (NF) • The first three editions of the NF provided practicing pharmacists with formulas for small scale compounding, allowing for competition with ready-made preparations. • 1916: National Formulary IV set “definite standards.” • 1935: The NF established a drug standards lab at the University of Illinois College of Pharmacy. • 1938: APhA established the Drug Standards Laboratory in Washington, DC.; during the 1960s, this lab was revitalized through financial support from USP (which was using this lab’s services) and the AMA. • In 1960, there were discussion of merging the NF and USP; by 1966, formal discussion of a merger was underway. • 1975: USP purchased both the NF and Drug Standards Laboratory from APhA. • 1998: USP licensed USP DI to The Thomson Company; USP DI is published by their Micromedex subsidiary. USP Today • “USP is a unique organization whose activities are directed by three governing bodies composed of more than 900 volunteers and whose day-to-day operations are managed by an executive team and staff of more than 800 employees.” • “Governance: USP is governed by the Convention membership, the Board of Trustees, and the Council of Experts and its Expert Committees. These decisionmaking bodies guide USP’s activities in the best interest of quality public health.” • “Executive Team: USP’s executive team helps manage all USP operations at its five international locations in support of the governing bodies’ standards-setting activities. USP staff provide support for volunteer and member activities, scientific testing, quality assurance, standards acquisition, verification services, training in developing regions, education programs, customer service, harmonization, and outreach and communications efforts.” Source: USP Web Site. USP Today USP’s Compendial Activities The United States Pharmacopeia and the National Formulary (USP–NF) Food Chemicals Codex USP Dietary Supplements Compendium USP Medicines Compendium (MC) Reference Standards Other Resources – Pharmacopeial Forum – FCC Forum – USP Dictionary – Chromatographic Columns USP Today • United States Pharmacopeia 38 - National Formulary 33 • Published November 1, 2014; official May 1, 2015 • Supplement 1 to the United States Pharmacopeia 38 - National Formulary 33 • Published February 1, 2015; official August 1, 2015 • Supplement 2 to the United States Pharmacopeia 38 - National Formulary 33 • Published June 1, 2015; official December 1, 2015 Rennebohm Hall n University of Wisconsin-Madison School of Pharmacy 777 Highland Avenue n Madison, WI 53705-2222 n 608.262.5378 n aihp@aihp.org This slide presentation was compiled and produced by Robert McCarthy, Ph.D., Professor and Dean Emeritus at the University of Connecticut School of Pharmacy for his class “The History of American Pharmacy.” Prof. McCarthy created this version of the slide talk for his class in the Spring of 2016. This slide presentation was downloaded from the Teaching the History of Pharmacy section of the website of the American Institute of the History of Pharmacy (https://aihp.org/historicalresources/teaching-the-history-of-pharmacy/) where a copy of the syllabus (.pdf) for Prof. McCarthy’s class is also available. This .pdf copy of the slide presentation was shared with the permission of Prof. Robert McCarthy for the personal and educational use of interested readers. PHRX 4001W-002 The History of American Pharmacy Spring 2016 ž The American Pharmaceutical industry was really born out of necessity during the American Revolution, when manufactured drugs were unavailable from Great Britain. ž Andrew Craigie, a Boston apothecary, was appointed to serve the Continental Army as Apothecary General; he developed a plan to establish a laboratory and storehouse for the production of drugs for medicine chests at Carlisle, Pennsylvania, the first largescale manufacturing of drugs in the United States. ž After the American Revolution. Philadelphia became the center of the fledgling American Pharmaceutical Industry. ž 1786: The Marshall brothers began manufacturing ammonium chloride and Glauber’s salt (decahydrate of sodium sulfate; used as a laxative). ž Although there were many patent drug makers prior to the 1850s, there were only a few American manufacturers producing drugs that pharmacists used in medication compounding. ž 1818: Farr & Kunzi (later named Powers & Weightman) • One of only two U.S. manufacturers to produce quinine sulfate in 1822, only two years after it was isolated from cinchona bark by two pharmacists in Paris. ž 1822: Rosengarten & Sons • Also produced quinine sulfate • Manufactured morphine salts in 1832 • Produced mercurials and strychnine in 1843 • Manufactured codeine in 1836 ž 1905: Powers & Weightman merged with Rosengarten & Sons ž 1927: Merck & Company acquired the Powers-Weightman-Rosengarten Company ž 1855: Frederick Stearns began manufacturing packaged medicinals at his Detroit pharmacy. ž 1856: William Warner (PA) began producing packaged medicines; later, he established a manufacturing plant that became the most successful manufacturer of sugar-coated tablets. ž Edward R. Squibb, who had apprenticed in a pharmacy, served in the U.S. Navy as assistant director of its pharmaceutical lab; after leaving the Navy, in 1858, he established E.R. Squibb, which began by producing “chemically pure ether and chloroform.” Source: American Pharmacists Association ž There were concerns in the 1850s about the growth of pharmaceutical manufacturers, who were taking preparing and dispensing away from community pharmacies; also, concerns that these manufacturers were not pharmacists and therefore not qualified to be manufacturing pharmaceuticals. ž The American pharmaceutical industry changed significantly during the Civil War as a result of the demands of the military. ž Some of the tensions between APhA, representing practicing pharmacists, and the pharmaceutical industry began to abate; in fact, several industry leaders assumed leadership roles within APhA. ž First began to appear in the 19th century ž Became popular as an alternative to “heroic” measures employed by physicians ž Were widely available in all types of stores ž Many were of little benefit and contained only alcohol, water, and flavoring ž Sales were greatly enhanced by advertising and personal testimonies ž The names of the company’s founder gave credibility to the products ž “Ethical” pharmaceutical company ž Sharp & Dohme (1860; later MS&D) ž Burroughs Wellcome & Company (1863) ž Eli Lilly & Company (1876) ž Lloyd (1870; later part of Hoechst Pharmaceuticals) ž McKesson & Robbins (1853; later a drug wholesaler) ž Parke, Davis & Company (1866) ž W.H. Schieffelin & Company (1865) ž Seabury & Johnson (1885) ž Smith, Kline, and Company (1875) ž John Wyeth & Brother (1860) Source: American Pharmacists Association Source: American Institute of the History of Pharmacy ž Until the early 20th century, pharmaceutical companies were primarily manufacturers, not focused on research & development. ž WWI led many American manufacturers, including Lilly, Merck, Parke-Davis, & Squibb to develop their own research facilities, though most cutting edge research was still conducted in Europe. ž After WWI, companies began early research efforts, primarily, at the start, to validate quality, purity, and assay. ž The advent of WII led the to first partnership among government, corporate, and academic institutions, which laid the foundation for what became known as “big pharma.” ž With the advent of WWII, international supplies of some products were not available, such as quinine, requiring American manufacturers to develop a source of these drugs. ž Manufacturers worked with the U.S. government in the development of drugs and biologicals needed for the war effort. ž Penicillin was one of the most important drugs developed during the war; ten U.S. pharmaceutical companies teamed in research & development efforts. ž The immediate post-war period saw the development of additional antibiotics and the first antihistamine (Benadryl by Parke-Davis). ž 1960-1980: A period of industry maturation; oral contraceptives, nonsteroidals, anti-inflammatories, cephalosporins, anxiolytics developed ž Post 1980: globalization, biotechnology & “blockbuster” drugs ž Recent years: Absence of targets ž Biotechnology • New companies: Genentec (1976), Biogen (1978), Amgen (1980), Immunex (1981) • Some companies brought their products from discovery to marketing, others licensed existing pharmaceutical companies to bring their products to market. ž Mergers & Acquisitions • Have occurred for decades, but have accelerated significantly in recent years – GlaxoSmithKline—previously Glaxo, Beecham, Smith, Kline, and French, Burroughs Wellcome, SmithKline Beecham, Glaxo Wellcome • Most mergers were horizontal, but the 1990s saw the acquisition of PBMs (vertical; Lilly acquired PCS); most of the mergers did not last long and the pharmaceutical companies divested within a few short years. 1907: American Association of Pharmaceutical Chemists (1920, name changed to the American Pharmaceutical Manufacturers Association) ž 1912: National Association of Manufacturers of Medicinal Products (1917, name changed to American Drug Manufacturers Association) ž 1958: These associations merged to become the Pharmaceutical Manufacturers Association (now called the Pharmaceutical Research and Manufacturers of America or PhRMA) ž “Big Pharma” ž ž 1946: Parenteral Drug Association ž 1955: National Association of Pharmaceutical Manufacturers; 1981: Generic Pharmaceutical Industry Association; these merged in 2001 to become the Generic Pharmaceutical Association. ž 1953: National Pharmaceutical Council— formed to do public relations for major research-oriented pharmaceutical manufacturers. Source: American Pharmacists Association Source: American Pharmacists Association Source: American Pharmacists Association Source: American Pharmacists Association Teaching History of Pharmacy According to the AIHP Guidelines: E. Growth of the Pharmaceutical Industry Created by: Karen Nagel-Edwards, PhD Midwestern University Chicago College of Pharmacy Reviewed by: Patricia Jusczak, BS Pharm University of Hawaii at Hilo, The Daniel K. Inouye College of Pharmacy Developed by the Teaching History of Pharmacy Committee of the History of Pharmacy SIG, 2017-18 Picture: Pharmacist at People’s Drug Store No. 5, Washington, DC, c. 1920. Library of Congress Prints and Photographs, LC-USZ62-129891 Italy • Earliest European development of chemical industry – 1294 – Venice – Venetian treacle was an important export – Monasteries got involved in industrial pharmaceutical activity (Florence) • Distilled waters • Cosmetics th 17 and th 18 Century • The first pharmaceutical manufacturing in England began with The Society of the Art and Mystery of the Apothecaries of the City of London – In 1623, the Society established a cooperative of apothecaries who agreed to produce Galenicals and chemicals on a large scale th 17 and th 18 Century • Robert Boyle (father of modern chemistry) and Ambrosius Gotfried Hanckwitz (Godfrey) – Built chemist’s shop with laboratory in London – Godfrey later transformed shop into world’s leading producer of phosphorus – Also prepared several chemicals and Galenicals th 17 and th 18 Century • Robert Boyle (father of modern chemistry) and Ambrosius Gotfried Hanckwitz (Godfrey) – Built chemist’s shop with laboratory in London – Godfrey later transformed shop into world’s leading producer of phosphorus – Also prepared several chemicals and Galenicals th 17 and th 18 Century • Antoine Baume – 1728-1804 – French chemist and pharmacist • • • • One of first in France to manufacture chemicals and Galenicals in large scale Transformed his shop into a manufacturing plant Inventor of a number of technical improvements to laboratory equipment Over 2400 products on his 1775 price list th 17 and th 18 Century • 1698: first drug patent – Epsom salts (magnesium sulfate heptahydrate) Revolutionary War Era • Continental Congress resolution (1775) – Established an Army Hospital – Staff included: • • • • Director-general and chief physician 4 surgeons 1 apothecary 20 mates • Resolution reorganizing the medical department (1777) – Apothecaries roles restricted to pharmaceutical ones Andrew Craigie – 1754-1819 – Appointed Apothecary General of all US military districts during American Revolution • Rank of Lieutenant Colonel • Accompanied physicians to battle • Apothecary job description separate and distinct from physician http://www.buyorkney.com/roots/biographies/img/andrew_craigie_jr.jpg Andrew Craigie – Role as Apothecary General: • Receive, prepare and deliver drugs (and instruments and shop furniture) to the army • Created and supervised large-scale compounding / chemical warehouse, the Elaboratory, to fill and deliver medicine chests to military hospitals and battlefields – Sets precedent for pharmacists to gain professional recognition – After war, became Apothecary General of the US Andrew Craigie 1st Apothecary General (17751783) at the Battle of Bunker Hill Revolutionary War Era • Main concerns with military drug supply – Drug shortages – Market speculations – Uncertain transport Methods of Treatment and Drugs Used During the Revolution • Antiseptic: Mercury (metals and salts) • Pain: Laudanum (a tincture of opium, saffron & Canary wine) • Laxative: Mercurous chloride (calomel), Glauber’s salt (sodium sulfate) • Syphilis: Larger doses of mercurous chloride • Malaria: Jesuits Bark (cinchona contains quinine) • Heart condit ... 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